Covid vaccine safety risks

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The EMA covid-19 data leak, and what it tells us about mRNA instability
The EMA covid-19 data leak, and what it tells us about mRNA instability
Leaked documents show that some early commercial batches of Pfizer-BioNTech’s covid-19 vaccine had lower than expected levels of intact mRNA, prompting wider questions about how to assess this novel vaccine platform, writes Serena Tinari As it conducted its analysis of the Pfizer-BioNTech covid-19 vaccine in December, the European Medicines Agency (EMA) was the victim of a cyberattack.1 More than 40 megabytes of classified information from the agency’s review were published on the dark web, and several journalists—including from The BMJ —and academics worldwide were sent copies of the leaks. They came from anonymous email accounts and most efforts to interact with the senders were unsuccessful. None of the senders revealed their identity, and the EMA says it is pursuing a criminal investigation. The BMJ has reviewed the documents, which show that regulators had major concerns over unexpectedly low quantities of intact mRNA in batches of the vaccine developed for commercial production. EMA scientists tasked with ensuring manufacturing quality—the chemistry, manufacturing, and control aspects of Pfizer’s submission to the EMA—worried about “truncated and modified mRNA species present in the finished product.” Among the many files leaked to The BMJ , an email dated 23 November by a high ranking EMA official outlined a raft of issues. In short, commercial manufacturing was not producing vaccines to the specifications expected, and regulators were unsure of the implications. EMA responded by filing two “major objections” with Pfizer, along with a host of other questions it wanted addressed. The email identified “a significant difference in % RNA integrity/truncated species” between the clinical batches and proposed commercial batches—from around 78% to 55%. The root cause was unknown and the impact of this loss of RNA integrity on safety and efficacy of the vaccine was “yet to be defined,” the email said. Ultimately, on 21 December, …
·bmj.com·
The EMA covid-19 data leak, and what it tells us about mRNA instability
Pandemrix vaccine: why was the public not told of early warning signs?
Pandemrix vaccine: why was the public not told of early warning signs?
Eight years after the pandemic influenza outbreak, a lawsuit alleging that GlaxoSmithKline’s Pandemrix vaccine caused narcolepsy has unearthed internal reports suggesting problems with the vaccine’s safety. Peter Doshi asks what this means for the future of transparency during public health emergencies In October 2009, the US National Institutes of Health infectious diseases chief, Anthony Fauci, appeared on YouTube to reassure Americans about the safety of the “swine flu” vaccine. “The track record for serious adverse events is very good. It’s very, very, very rare that you ever see anything that’s associated with the vaccine that’s a serious event,”1 he said. Four months earlier, the World Health Organization had declared H1N1 influenza a pandemic, and by October 2009 the new vaccines were being rolled out across the world. A similar story was playing out in the UK, with prominent organisations, including the Department of Health, British Medical Association, and Royal Colleges of General Practitioners, working hard to convince a reluctant NHS workforce to get vaccinated.2 “We fully support the swine flu vaccination programme … The vaccine has been thoroughly tested,” they declared in a joint statement.3 Except, it hadn’t. Anticipating a severe influenza pandemic, governments around the world had made various logistical and legal arrangements to shorten the time between recognition of a pandemic virus and the production of a vaccine and administration of that vaccine in the population. In Europe, one element of those plans was an agreement to grant licences to pandemic vaccines based on data from pre-pandemic “mock-up” vaccines produced using a different virus (H5N1 influenza). Another element, adopted by countries such as Canada, the US, UK, France, and Germany, was to provide vaccine manufacturers indemnity from liability for wrongdoing, thereby reducing the risk of a lawsuit stemming from vaccine related injury.45 In …
·bmj.com·
Pandemrix vaccine: why was the public not told of early warning signs?
These NHS Staff Were Told The Swine Flu Vaccine Was Safe, And They're Suffering The Consequences
These NHS Staff Were Told The Swine Flu Vaccine Was Safe, And They're Suffering The Consequences
Dozens of NHS workers are fighting for compensation after developing narcolepsy from a swine flu vaccine that was rushed into service without the usual testing when the disease spread across the globe in 2009. They say it has destroyed their careers and their health.
·buzzfeed.com·
These NHS Staff Were Told The Swine Flu Vaccine Was Safe, And They're Suffering The Consequences
Arise, AstraZeneca!
Arise, AstraZeneca!
Simon Elmer In the UK today, it seems, being knighted means you’re someone the UK state wishes to protect from prosecution for crimes against the British people. We don’t need to point to Sir Tony …
·off-guardian.org·
Arise, AstraZeneca!
The Victims of AstraZeneca
The Victims of AstraZeneca
Simon Elmer This is a follow-up to the article Arise, AstraZeneca, which was published earlier today Dr Stephen Wright On 16 January, 2021, Dr. Stephen Wright, a healthy 32-year-old child psycholog…
·off-guardian.org·
The Victims of AstraZeneca
Supporting evidence re concerns surrounding COVID-19 vaccination in children - full open letter to MHRA 17-05-2021 – HART
Supporting evidence re concerns surrounding COVID-19 vaccination in children - full open letter to MHRA 17-05-2021 – HART
Supporting evidence re concerns surrounding COVID-19 vaccination in children Dr June Raine, CEO, Medicines & Healthcare devices Regulatory Authority, cc: Professor Lim, Chairman, JCVI Covid-19 vaccines committee cc: Professor Chris Whitty, CMO, Co-chair of SAGE cc: Sir Patrick Vallence, Chief Scientific Officer, Co-chair of SAGE Dear Dr Raine, We wish to notify you of our […]
·hartgroup.org·
Supporting evidence re concerns surrounding COVID-19 vaccination in children - full open letter to MHRA 17-05-2021 – HART